Recall Z-2694-2026 ยท GXI Probe, Radiofrequency Lesion
Boston Scientific Neuromodulation Corporation
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADD
| Date | Jul 8, 2026 (initiated Apr 22, 2026) |
| Status | Open, Classified |
| Reason | Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection. |
| Root cause | Packaging process control |
| Action | On 4/22/2026, removal notices were mailed to materials managers and health care professionals who were asked to do the following: 1) Segregate affected devices until they can be returned to firm. 2) Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 3) Forward this notice to any healthcare professional from your organization for awareness and to any organization to which affected devices have been transferred. 4) Complete and return the enclosed Reply Verification Tracking |
| Quantity | 37,764 |
| Distribution | Worldwide - US Nationwide distribution including in the states of NJ, WI, MI, MN, AR, UT, OH, FL, CA, TX, PA, AZ, IN, LA, NE, OK, NY, MD, WY, CO, NC, IL, GA, WA, KS, AL, MO, VA, TN, KY, MS, MA, SC, OR, WV, MT, ID, SD, CT, NV, ND, NH, DE, NM, AK, IA, DC, HI, ME, VT, RI and the countries of Great Brit |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222281 | Intracept Intraosseous Nerve Ablation System Relievant Medsystems, Inc., Oct 26, 2022 |